ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets…
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
60 FDA recalls mention Aspirin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Aspirin.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled…
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Reason Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Failed Stability Specifications
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Presence of Foreign Substance: foreign material found in the bulk inventory.
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Reason Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Reason Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Reason Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Reason Failed Dissolution Specification; at the 12 month time interval.
Reason Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL…
Reason Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 0 mg…
Reason Labeling: Label Mixup: ASPIRIN, CHEW Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule…
Reason Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 120 mg…
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